Compliance Training Webinars for Regulated Industries

This webinar will focus on the regulatory and design requirements for an effective change control system in the pharmaceutical industry. Attendees will learn the role and importance of change control system in implementing an effective quality system.

Understanding Tokenization and its Supporting Technologies - A Guide to Converting Real-World Assets into Digital Tokens on Blockchain Web3 tokenization is a revolutionary concept that converts real-world assets or rights into digital tokens on a blockchain, allowing for secure and decentralized ownership, access, and value transfer. Unlike simple digital currencies, Web3 tokens can represent physical assets, intellectual property, or utility and governance rights within decentralized applications (dApps). This enables fractional ownership of assets, like real estate, and enhances investment opportunities without traditional intermediaries. As a key driver of the decentralized economy, Web3 tokenization is reshaping asset management and participation in digital ecosystems.

This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits.

This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.

It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.

China’s Life Sciences Compliance webinar will discuss the regulatory structure and requirements for compliance against China’s NMPA regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.

This webinar explains what actions should be taken following an unexpected positive result in a sterility test on a biological indicator (BI) during performance qualification or routine testing. It also addresses the actions to take when a test of sterility demonstrates unexpected growth during validation or routine dose audits. The various items that should be investigated to determine the root cause and the follow up to the investigation will be covered.

Learn how to use Learning Management Systems (LMS) to create effective pharma training curricula and ensure GMP compliance. This webinar delves into the unique challenges of creating intuitive job position curricula, overcoming LMS limitations, and meeting FDA requirements. Discover how to define true pharma curricula, collect job function details, manage complex training needs, and demonstrate compliance during audits. Ideal for professionals looking to optimize training in pharmaceutical environments.

This webinar is focused on the Quality Management System' oversight of manufacturing and its documentation. What is required of a compliant system according to ISO 9001, 21 CFR 820 / ISO 13485, and 21 CFR 210 and 211 ..

This 1-hour webinar will go into the specifics of the REACH and RoHS regulations and review the latest amendments and changes to both regulations for 2024. We will draw out key developments and key dates (if applicable) with particular emphasis on requirements for US firms.

Performing a corporate wide risk assessment is doable, and can provide internal audit and its organization a roadmap for the upcoming audit year. In this webinar, participants will learn how to maximize the time spent on the risk assessment process on an annual basis.

Processing ACH Reclamations from the Federal Government can be challenging! Chapter 5 of the Green Book has been updated making it mandatory for Financial Institutions to respond to all reclamations must be submitted through the Automated Reclamation Processing System (ARPS) located in Treasury’s Pay.gov web portal (except for responses by DFAS and any Treasury-approved exceptions). The Nacha Operating Rules still apply when processing these payments but the Green Book outlines exceptions when handling DNEs (Death Notification Entries) and Federal Government Reclamations. A side-by-side comparison of Commercial vs. Government Reclamations will be included to know what the difference is and how to handle each one.

This webinar will focus on the Process for Quality Agreements and requirements that must be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn the reason for implementing a Quality Agreement system to assure adequate controls for Service Providers.

This webinar will discuss the basics of what is required in a Storm Water Pollution Prevention Plan (SWPPP), how to develop and implement and formalized SWPPP and address site-specific questions and scenarios.

This webinar addresses the Computer Software Assurance guidance related to 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications. It details the evolution of industry practices that increase productivity and ensure compliance. Learn the latest validation models and fill-in-the-blank templates.

This course will give an introduction into the Medical Device Single Audit Program (MDSAP) and how to adjust your internal audit program. The introduction will give an overview about the requirements for the quality management system and how to conduct an internal audit with MDSAP requirements to check, if your quality management system meet all MDSAP requirements.

This training will review the best practices establishing and conducting a cleaning validation for reusable medical devices. It will also address the requirements of ANSI/AAMI ST 98.

Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.

This 60-minute session on master verification and validation planning will discuss the major cGMP deficiencies and "must have" elements from the U.S. FDA cGMP, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.

In this training program attendees will learn the key elements needed to develop a proactive Regulatory Compliance Written Program. After this webinar, you will have confidence in facing the next EPA regulatory compliance audit that comes your way.